USFDA: Glenmark, Alembic, Sun Pharma Recall Products

New Delhi, Aug 18 (PTI) Drug makers Glenmark, Alembic Pharmaceuticals and Sun Pharma are recalling products in the US due to manufacturing issues, according to the US health regulator.

Mumbai-based Glenmark is recalling two products in the market, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report.

Glenmark Pharmaceuticals Inc, USA, a subsidiary of the company, is recalling Carvedilol tablets, used to treat heart failure, hypertension, and heart attack, in multiple strengths.

The New Jersey-based firm is recalling 55,560 units of the affected lot due to "presence of a nitrosamine, N-Nitroso Carvedilol impurity above the current acceptable intake level," the USFDA stated.

The company is also recalling 17,496 bottles of Carvedilol tablets as "results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm," it added.

Glenmark initiated the Class II recall in August this year.


USFDA said the company is also recalling 22,656 bottles of Theophylline extended-release tablets (400 mg) for failed dissolution specifications.

Alembic Pharmaceuticals is recalling 9,492 bottles of Doxepin Hydrochloride capsules, used in the treatment of insomnia, the US health regulator stated.

The Class II recall is due to the "Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit," it said.

The company initiated the recall on July 25 this year.

New Jersey-based Sun Pharmaceutical Industries Inc is recalling 11,328 bottles of Spironolactone Tablets, used to treat high blood pressure, due to "Presence of foreign substance: identified as aluminum," the regulator said.

The company commenced the Class II recall on August 5.

As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.